Pakistan Drug Regulatory Authority Act 2012 (Act No. XXI of 2012)

1. Key takeaways

The root of all medical device rules in Pakistan is the Drug Regulatory Authority of Pakistan Act, 2012, enacted as Act No. XXI of 2012. Two provisions in that Act matter most for device companies. First, s.23 authorises DRAP to make rules with the approval of the federal government — MDR 2017 and all of its amendment orders (S.R.O.s) derive from this single power. Second, s.36 authorises exemptions — the enlistment and registration exemption period in Rule 52 of MDR 2017 was established on this basis. Read together, the two provisions explain both how the device regime was built and how it moves: one clause creates the subordinate legislation that companies file under, and the other clause created the transitional relief that allowed the market to adjust. Anyone advising on Pakistan should be able to quote both provisions by number without looking them up, because nearly every practical question about procedures or transitional treatment resolves back to one of them.

• Every device obligation in Pakistan ultimately traces back to one parent statute, the DRAP Act, 2012.
• The operating rules are subordinate legislation, created and revised by DRAP itself under s.23.
• Exemption windows created under s.36 have all expired, so no class now enjoys a simplified path.
• Citation practice should follow the hierarchy: Act, then Rules, then amendment orders.

2. Legal basis

The table below consolidates the provisions of the Act that drive the device regime, together with the instruments that were made under them. It is the reference point for any citation used in a Pakistani dossier. Note that the pharmacovigilance duty in s.4(1)(g) is exercised through the Pharmacy Services Division, which is why vigilance matters sit outside the device division even though they cover devices as part of therapeutic goods.

3. Expert insights

Insight 1: Understanding s.23 means understanding Pakistan’s legislative tempo. Because the rules are made by DRAP rather than through the legislature, the amendment frequency is high — two amendments in 2022 (S.R.O. 430 and 559), one in 2023 (S.R.O. 224), and one in 2025 (S.R.O. 1399). This is both bad news (positions change) and good news (corrections come quickly). A team that treats the rules as static will be caught out by the next amendment order, because the operating details — forms, fees, definitions, specific procedures — are exactly what the S.R.O.s revise. The correct posture is to re-verify the current text before every submission cycle, not to rely on a version of the rules saved on a shared drive from a previous project. Amendment orders in Pakistan are gazette notifications, and they take effect on publication, so the window between a change and its practical impact is short.

Insight 2: The s.36 exemption was a double-edged sword. MDR 2017 Rule 52 once granted exemptions running to 2023-12-31 for Class C/D and to 2024-12-31 for Class A/B, but the exemption carried conditions: it applied only to importers or local manufacturers holding an establishment licence, and designated documents had to be submitted at clearance. The exemption periods have now all expired, and all classes must go through the full enlistment or registration procedure. Companies that structured their 2023 and 2024 imports around the conditional exemption window should treat that chapter as closed; legacy arguments based on the expired exemption have no footing for new consignments. The expiry also changed the compliance baseline for distributors, who should now expect every imported device, regardless of class, to arrive with a valid enlistment or registration certificate behind it.

Insight 3: The legal hierarchy determines how to cite. The parent Act is the source of the system, the Rules are the operating basis, and S.R.O.s are amendment orders. External documents should cite across all three layers — Act, Rules, amendment order — instead of writing a vague reference to “DRAP regulations”. A precise citation does two jobs at once: it demonstrates to the reviewer that the applicant knows the framework, and it pins the submission to a verifiable version of the text, which matters precisely because the amendment tempo is high. It also protects the applicant in later disputes, because when DRAP positions shift through a new S.R.O., the dossier shows exactly which version it relied upon at the time of filing.

4. Practical recommendations

• GRZAN requires the cover page of every Pakistan project dossier to state: the version of the rules relied upon, plus the numbers of the applicable amendment orders, plus the verification date.
• Our citation format is fixed: Medical Devices Rules, 2017 (gazetted 16 January 2018), Rule 13 / Rule 14 / Rule 15, with the applicable S.R.O. numbers listed separately.
• Any statement involving fees always carries the annotation “subject to the current Schedule C”.
• Before each submission, the three citation layers are re-checked against the gazette, so that no dossier cites a superseded amendment order.
• Historical exemption arguments are never used for new consignments, because all Rule 52 exemption windows have expired.

5. Verification checklist

• □ Legal citations use the full four elements: name + act number + date + provision number
• □ The two levels, the Act and the Rules, are kept distinct in all documents
• □ The applicable S.R.O. amendment numbers are listed
• □ Fee statements carry the annotation “subject to the current Schedule C”
• □ The verification date 2026-10-28 is marked

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