Pakistan Medical Device Regulator: DRAP, MD&MC Division and MDB

1. Key takeaways

The competent authority for medical devices and in vitro diagnostics in Pakistan is the Drug Regulatory Authority of Pakistan (DRAP), which operates under the Ministry of National Health Services, Regulations and Coordination (MoNHSRC). DRAP is headquartered at the Prime Minister’s National Health Complex, Chak Shahzad, Park Road, Islamabad. Within DRAP, the Medical Devices and Medicated Cosmetics Division (MD&MC Division, commonly referred to in industry as MDMC) handles device affairs, while the Medical Devices Board (MDB) is responsible for review and evaluation. The three-layer structure can be summarised as follows: DRAP is the authority, MDMC is the executive division, and MDB is the review body. Devices enter the market either through enlistment for Class A or through registration for Class B, C and D, and in both cases the application file passes through MDMC before any conclusion is reached at board level. For a foreign manufacturer, the practical consequence is that every submission, every deficiency response and every certificate milestone in Pakistan is routed through this same three-layer machine, and knowing which layer owns which step is the first thing to fix before drafting a single page of the dossier.

• Regulatory decisions on devices are made inside a pharmaceutical-style authority, not a standalone device agency.
• Day-to-day device processing sits with MDMC; scientific conclusions sit with MDB.
• Applications are filed and updated through the DRAP e-Service portal.
• Post-market vigilance reporting runs through the National Pharmacovigilance Centre (NPC).

2. Legal basis

The table below maps each regulatory item to its legal source and the specific provision on which it rests. All references are reproduced exactly as they appear in the underlying instruments, because an inaccurate citation is itself a compliance risk: DRAP reviewers check citations, and a wrong section number in a cover letter signals that the applicant does not know the framework. The two instruments that matter most are the DRAP Act, 2012, which creates the authority and grants its powers, and the Medical Devices Rules, 2017, which contain the operating procedures for devices.

3. Expert insights

Insight 1: DRAP’s jurisdiction is much broader than “devices”. Under the DRAP Act, 2012, it is the competent authority for therapeutic goods. Drugs, biologics, vaccines and blood products, alternative medicine products, OTC and health products, medical devices and medicated cosmetics all sit inside the same regulatory system. Devices were placed within this framework rather than given a separate one, and this single design choice determines the pharmaceutical character of every device procedure in Pakistan. When planning a submission, companies should therefore expect drug-style administrative requirements — establishment-level licensing, batch-level import documentation and formal pharmacovigilance duties — rather than the lighter arrangements found in some device-only regimes. Understanding this framing early prevents misreading routine DRAP requirements as unusual or negotiable obstacles later in the project.

Insight 2: MDMC is the executive layer, not the decision-making layer. Device enlistment and registration, establishment licences, and import and export permits are processed by MDMC, but review and evaluation are decided by MDB. Companies frequently conflate the two bodies in project communication — deficiency requests come from the MDMC technical team, while approval or rejection is issued by MDB. This distinction matters practically. A letter from MDMC asking for additional documents is part of processing, not the final verdict, and responses should be addressed back through the same executive channel. Conversely, chasing MDMC staff for a decision that only MDB can make wastes time and creates friction. Project plans should name both bodies separately, with the correct owner attached to each milestone, so that escalation paths are clear from the outset.

Insight 3: The composition of MDB explains why review leans clinical. Under S.R.O. 32(I)/2018, MDB consists of federal and provincial officials together with experts in urology, nephrology, radiology, biomedical engineering, software and mechatronics engineering, internal medicine, orthopaedic and cardiovascular surgery, interventional cardiology, pathology, medical technology and pharmacy. This is a technical board with a clinical majority, so dossiers should be oriented towards clinical evidence and use-related risk rather than mere document completeness. A submission that only proves paperwork compliance, without connecting the evidence to patient safety and clinical performance as used in Pakistani hospitals and clinics, is weaker before this audience than the same file would be before a purely administrative reviewer. Companies coming from markets with administrative-only review often underestimate this: the questions raised by MDB tend to probe intended use, indications, contraindications and real-world failure modes, and a dossier prepared with those questions in mind moves through review with fewer cycles of deficiency correspondence.

4. Practical recommendations

• When GRZAN takes over a Pakistan project, it first draws a “three-layer mapping chart” for the client.
• Questions for MDMC: acceptance, deficiency responses, certificate issuance and data updates.
• Questions decided by MDB: review conclusions, whether a site inspection can be waived, whether samples are required.
• Items belonging to other departments: vigilance reporting goes to the NPC, import clearance goes through the Pakistan Single Window (PSW).
• This chart is issued to the client at the project kick-off meeting, so that acceptance-stage issues are not misjudged as review-stage issues and cause delay.
• Every communication is tagged with the layer it belongs to, which keeps escalation paths clean.

5. Verification checklist

• □ Confirmed that the competent authority is DRAP (under MoNHSRC, Islamabad)
• □ Distinguished the three layers: DRAP (authority), MDMC (executive division) and MDB (review body)
• □ Confirmed that application acceptance and data updates run through the e-Service portal
• □ Confirmed that the vigilance reporting entry point is the National Pharmacovigilance Centre (NPC)
• □ Confirmed that import clearance goes through the Pakistan Single Window (PSW) from 2026

Regulatory information verified as of 28 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across South Asia, including Pakistan. Our team prepares dossiers to DRAP expectations, manages eCTD-format submissions and deficiency responses, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com